OMNISCAN- gadodiamide injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

gadodiamide (UNII: 84F6U3J2R6) (gadodiamide - UNII:84F6U3J2R6)

MAH:

GE Healthcare Inc.

INN:

gadodiamide

composition:

gadodiamide 287 mg in 1 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1)]. OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2)]. OMNISCAN is contraindicated in patients with: - Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2 ) or acute kidney injury - Prior hypersensitivity to OMNISCAN GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. Because of the potential risks of gadolinium to the fetus, use OMNISCAN only if imaging is essential during pregnancy and cannot be delayed. Contrast enhancement is visualized in the human placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates. However, a retrospective cohort study, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the maternal indication for MRI. Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy. GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. OMNISCAN has been shown to have an adverse effect on embryo-fetal development in rabbits at dosages as low as 0.5 mmol/kg/day for 13 days during gestation (approximately 0.6 times the human dose based on a body surface area comparison). These adverse effects are observed as an increased incidence of flexed appendages and skeletal malformations which may be due to maternal toxicity since the body weight of the dams was reduced in response to OMNISCAN administration during pregnancy. In rat studies, fetal abnormalities were not observed at doses up to 2.5 mmol/kg/day for 10 days during gestation (1.3 times the maximum human dose based on a body surface area comparison); however, maternal toxicity was not achieved in these studies and a definitive conclusion about teratogenicity in rats at doses above 2.5 mmol/kg/day cannot be made. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when administering OMNISCAN to a nursing woman. The safety and efficacy of OMNISCAN at a single dose of 0.05 to 0.1 mmol/kg have been established in pediatric patients over 2 years of age based on adequate and well controlled studies of OMNISCAN in adults, a pediatric CNS imaging study, and safety data in the scientific literature. However, the safety and efficacy of doses greater than 0.1 mmol/kg and of repeated doses have not been studied in pediatric patients. Pharmacokinetics of OMNISCAN have not been studied in pediatrics. The glomerular filtration rate of neonates and infants is much lower than that of adults. The pharmacokinetics volume of distribution is also different. Therefore, the optimal dosing regimen and imaging times in patients under 2 years of age have not been established. In clinical studies of OMNISCAN, 243 patients were between 65 and 80 years of age while 15 were over 80. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity in the elderly cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. OMNISCAN is excreted by the kidney, and the risk of toxic reactions to OMNISCAN may be greater in patients with impaired renal function [see Warnings and Precautions (5.4)]. Because elderly patients are more likely to have decreased renal function, select dose carefully and consider assessment of renal function before OMNISCAN use. Dose adjustments in renal or hepatic impairment have not been studied. Caution should be exercised in patients with impaired renal insufficiency [see Warnings and Precautions (5.2, 5.5) ].

leaflet_short:

OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide in rubber stoppered vials and polypropylene syringes. OMNSICAN is supplied in the following sizes: 10 mL vial, box of 10 (NDC 0407-0690-30) 15 mL fill in 20 mL vial, box of 10 (NDC 0407-0690-40) 20 mL vial, box of 10 (NDC 0407-0690-50) 15 mL fill in 20 mL prefilled syringe, box of 10 (NDC 0407-0690-42) 20 mL prefilled syringe, box of 10 (NDC 0407-0690-43) Protect OMNISCAN from strong daylight and direct exposure to sunlight. Do not freeze. Freezing can cause small cracks in the vials, which would compromise the sterility of the product. Do not use if the product is inadvertently frozen. Store OMNISCAN at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP].

authorization_status:

New Drug Application

PIL

GE Healthcare Inc.
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MEDICATION GUIDE
OMNISCAN™ (OMNI-scan)
(gadodiamide)
Injection for intravenous use
What is OMNISCAN?
•
OMNISCAN is a prescription medicine called a gadolinium-based contrast
agent (GBCA).
OMNISCAN, like other GBCA medicines, is used with a magnetic resonance
imaging (MRI)
scanner.
•
An MRI exam with a GBCA, including OMNISCAN, helps your doctor to see
problems better
than an MRI exam without a GBCA.
•
Your doctor has reviewed your medical records and has determined that
you would benefit from
using a GBCA with your MRI exam.
What is the most important information I should know about OMNISCAN?
•
OMNISCAN contains a metal called gadolinium. Small amounts of
gadolinium can stay in your
body including the brain, bones, skin and other parts of your body for
a long time (several months
to years).
•
It is not known how gadolinium may affect you, so far, studies have
not found harmful effects in
patients with normal kidneys.
•
Rarely, patients have reported pains, tiredness, and skin, muscle or
bone ailments for a long time,
but these symptoms have not been directly linked to gadolinium.
•
There are different GBCAs that can be used for your MRI exam. The
amount of gadolinium that
stays in the body is different for different gadolinium medicines.
Gadolinium stays in the body
more after Omniscan or Optimark than after Eovist, Magnevist, or
MultiHance. Gadolinium stays
in the body the least after Dotarem, Gadavist, or ProHance.
•
People who get many doses of gadolinium medicines, women who are
pregnant and young
children may be at increased risk from gadolinium staying in the body.
•
Some people with kidney problems who get gadolinium medicines can
develop a condition with
severe thickening of the skin, muscles and other organs in the body
(nephrogenic systemic
fibrosis). Your healthcare provider should screen you to see how well
your kidneys are working
before you receive OMNISCAN.
Do not receive OMNISCAN if you have had a severe allergic reaction to
OMNISCAN.
Before receiv

SPC

OMNISCAN- GADODIAMIDE INJECTION
GE HEALTHCARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMNISCAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMNISCAN.
OMNISCAN™ (GADODIAMIDE) INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
WARNING: NOT FOR INTRATHECAL USE AND NEPHROGENIC SYSTEMIC FIBROSIS
(NSF)
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NOT FOR INTRATHECAL USE:
INADVERTENT INTRATHECAL USE OF OMNISCAN HAS CAUSED CONVULSIONS, COMA,
SENSORY
AND MOTOR NEUROLOGIC DEFICITS (5.1).
NSF:
GADOLINIUM-BASED CONTRAST AGENTS (GBCAS) INCREASE THE RISK FOR NSF
AMONG PATIENTS
WITH IMPAIRED ELIMINATION OF THE DRUGS. AVOID USE OF GBCAS IN THESE
PATIENTS UNLESS
THE DIAGNOSTIC INFORMATION IS ESSENTIAL AND NOT AVAILABLE WITH
NON-CONTRASTED MRI OR
OTHER MODALITIES.
DO NOT ADMINISTER OMNISCAN TO PATIENTS WITH:
CHRONIC, SEVERE KIDNEY DISEASE (GFR < 30 ML/MIN/1.73M ), OR
ACUTE KIDNEY INJURY (4).
SCREEN PATIENTS FOR ACUTE KIDNEY INJURY AND OTHER CONDITIONS THAT MAY
REDUCE RENAL
FUNCTION. FOR PATIENTS AT RISK FOR CHRONICALLY REDUCED RENAL FUNCTION
(E.G., AGE > 60
YEARS, HYPERTENSION OR DIABETES), ESTIMATE THE GLOMERULAR FILTRATION
RATE (GFR)
THROUGH LABORATORY TESTING (5.2).
RECENT MAJOR CHANGES
Warnings and Precautions, Gadolinium Retention (5.4)
04/2018
Adverse Reactions, Post-Marketing Experience (6.3)
01/2018
INDICATIONS AND USAGE
OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic
resonance imaging (MRI)
indicated for intravenous use to:
Visualize lesions with abnormal vascularity in the brain, spine, and
associated tissues (1.1)
Facilitate the visualization of lesions with abnormal vascularity
within the thoracic, abdominal, pelvic
cavities, and the retroperitoneal space (1.2)
DOSAGE AND ADMINISTRATION
CNS – Adults and Pediatrics; 2-16 years of age: 0.2 mL/kg (0.1
mmol/kg) (2.1, 2.4)
Body – Adults and Pediatrics; 2-16 years of age: Kidney: 0.1 mL/kg
(0.05 mmol/kg)
Intrathoracic, intra-abd